K172985 is an FDA 510(k) clearance for the Ligation Device, a Ligator, Hemorrhoidal (Class II — Special Controls, product code FHN), submitted by Leo Medical Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on June 14, 2018, 260 days after receiving the submission on September 27, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K172985 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2017 |
| Decision Date | June 14, 2018 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FHN — Ligator, Hemorrhoidal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |